AZD0530 in Treating Patients With Recurrent Locally Advanced or Metastatic Soft Tissue Sarcoma
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|ClinicalTrials.gov Identifier: NCT00659360|
Recruitment Status : Completed
First Posted : April 16, 2008
Results First Posted : July 30, 2015
Last Update Posted : June 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Adult Fibrosarcoma Adult Leiomyosarcoma Adult Liposarcoma Adult Malignant Fibrous Histiocytoma Adult Rhabdomyosarcoma Dermatofibrosarcoma Protuberans Endometrial Stromal Sarcoma Recurrent Adult Soft Tissue Sarcoma Recurrent Uterine Sarcoma Stage III Adult Soft Tissue Sarcoma Stage III Uterine Sarcoma Stage IV Adult Soft Tissue Sarcoma Stage IV Uterine Sarcoma Uterine Carcinosarcoma Uterine Leiomyosarcoma||Drug: saracatinib||Phase 2|
I. To assess the efficacy of AZD0530, in terms of disease control rate (i.e., response rate and stable disease rate), in patients with recurrent locally advanced or metastatic soft tissue sarcoma.
II. To assess the toxicity, time to progression, and response duration of AZD0530 in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 8 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of AZD0530 in Recurrent or Metastatic Soft Tissue Sarcoma|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||November 2012|
Experimental: Arm I
Patients receive oral AZD0530 (saracatinib ) at a dose of 175 mg, once daily, in the absence of disease progression or unacceptable toxicity.
Other Name: AZD0530
- Disease Control Rate, Defined as the Number of Patients Who Achieved Complete Response, Partial Response or Stable Disease For a Period of More Than 4 Months. [ Time Frame: Up to 5 years ]Response and progression will be evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Changes in only the largest diameter (unidimensional measurement) of the tumor lesions; where CR is disappearance of all target lesions, PR is at least 30% decrease in the sum of longest diameter, PD is at least 20% increase in the sum of longest diameter recorded since the treatment started and SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD
- Objective Response Rate [ Time Frame: Up to 5 years ]Complete Response (CR) - Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions
- Overall Survival [ Time Frame: Up to 5 years ]Median was estimated. The Kaplan-Meier method will be used to estimate overall survival estimates.
- Stable Disease Rate [ Time Frame: Up to 5 years ]Achieved stable disease as their best response
- Duration of Response [ Time Frame: Up to 5 years ]
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions;
Objective Tumor Response "of more than 4 months" was counted toward the Disease Control Rate.
- Time to Disease Progression [ Time Frame: Up to 5 years ]
The Kaplan-Meier method will be used to estimate time to progression estimates.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00659360
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Rockledge, Pennsylvania, United States, 19046|
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|University Health Network-Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Montreal General Hospital|
|Montreal, Quebec, Canada, H3G 1A4|
|Principal Investigator:||Margaret von Mehren||University Health Network-Princess Margaret Hospital|